Related Experiment Video
Updated: Oct 9, 2026
The CYP2D6 Animal Model: How to Induce Autoimmune Hepatitis in Mice
Published on: February 3, 2012
At least three hepatitis C virus strains implicated in Swedish and Danish patients with intravenous
A Widell1, Y Y Zhang, B Andersson-Gäre
1Department of Medical Microbiology, University Hospital Malmö, Sweden.
Insights
Hepatitis C virus (HCV) outbreak linked to Gammagard intravenous immunoglobulin revealed multiple strains. Investigations identified subtypes 1a and 2b, with some patients infected by several strains from contaminated batches.
Area of Science:
- Virology
- Immunology
- Public Health
Background:
- Identified a worldwide hepatitis C virus (HCV) outbreak linked to non-solvent/detergent (SD)-treated Gammagard intravenous immunoglobulin.
- Prompted recall of implicated Gammagard batches and tracing of exposed patients in Sweden and Denmark.
- Highlighted the risk of viral transmission through immunoglobulin products.
Purpose of the Study:
- To investigate the genetic diversity of hepatitis C virus (HCV) strains in patients exposed to implicated Gammagard batches.
- To determine the relationship between patient isolates and Gammagard batches through molecular analysis.
Main Methods:
- Conducted hepatitis C virus genotyping and sequencing of the core region and E2 hypervariable region 1 on sera from 14 exposed patients.
- Performed genomic amplification on 15 non-SD-treated Gammagard batches.
- Utilized isolate-specific primers for amplification and genomic fingerprinting for sequence confirmation.
Main Results:
- Identified HCV subtypes 1a (12 patients) and 2b (2 patients) among exposed individuals.
- Found identical core region sequences in four patients and one Gammagard batch, suggesting a common source.
- Detected unique and shared sequences within subtype 1a isolates, and identical sequences within subtype 2b isolates, indicating multiple contaminating strains.
Conclusions:
- The implicated Gammagard batches were likely contaminated with multiple hepatitis C virus strains.
- This contamination led to the observed outbreak and diverse viral subtypes in patients.
- Emphasizes the critical need for stringent viral inactivation and quality control in blood product manufacturing.
Background:
Three reported Swedish cases of hepatitis C in patients receiving an intravenous immunoglobulin (Gammagard, Baxter Healthcare, Deerfield, IL) were among the first to bring to light a worldwide outbreak of hepatitis C associated with non-solvent/detergent (SD)-treated Gammagard. In February 1994, all implicated batches of Gammagard were recalled and exposed patients traced.
Study Design And Methods:
Sera from all identified and hepatitis C-viremic Swedish and Danish patients (n = 14) exposed to the implicated batches underwent hepatitis C virus genotyping and sequencing of the core region and hypervariable region 1 of E2. Genomic amplification was also done on 15 non-SD-treated batches of Gammagard.
Results:
Twelve patients were infected with subtype 1a and surprisingly, two with subtype 2b. Analysis of the core region showed identical sequences in four patients and the only consistently positive batch. Five patients shared another sequence, whereas three other subtype 1a patients each manifested unique sequences. The two subtype 2b isolates were identical. Genomic fingerprinting of the hypervariable region confirmed identity within each group with great stringency. Amplification with isolate-specific primers showed mixed infection in one patient whose exposure was confined to a single batch.
Conclusion:
The few batches implicated presumably were contaminated with several strains.
Related Concept Videos
01:25Hepatitis
01:30Inhibitors of Viral Protein Synthesis
01:28Viral Hepatitis I: Introduction